F17.2
Conditions
Interventions
Group 1: Treatment-as-usual (TAU) + Cognitive Bias Modification (using the Approach-Avoidance Task [AAT])
Treatment-as-usual (Smoke-free® program,): for further information see: https://www.rauchfrei-
Sponsors
Ludwig-Maximilians-Universität München
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: i. Age 18-70 years ii. CO = 10 ppm iii. Fagerstrøm Test for Nicotine Dependence = 3 iv. Consumption of at least 10 cigarettes daily within the last 12 months v. No consumption of nicotine replacement therapy (NRT) and no pharmacological smoking cessation therapry 3 months prior to study participation vi. Willingness to abstain from NRT, e-cigarettes and any other smoking cessation intervention during study participation vii. Interest to participate in the smokefree program
Exclusion criteria
Exclusion criteria: i. Severe psychiatric disorder (e.g., bipolar disorder, psychosis) ii. Severe neurological disorder (e.g., z.B. Morbus Parkinson, multiple sclerosis) iii. Acute suicidality iv. Moderate substance dependence (> criteria fulfilled according to DSM-5; except tobacco) v. Pregnancy or nursing vi. Insufficient knowledge of German language
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Abstinence at the 6-month follow-up, defined by the following criteria (Russell Standard, see West et al., 2005) (7)Sustained period of abstinence (8)Sustained abstinence is defined as smoking not more than five cigarettes from start of the abstinence period and biochemical verification. (9)Biochemische Überprüfung (CO-Test): CO = 9ppm. (10)Intention-to-treat Analyse (11)Berücksichtigung von Teilnehmer/-innen bei der Analyse, die das Studienprotokoll verletzt haben (z.B. Einnahme von Nikotinersatzpräparaten) (12)Die Follow-Up Erhebung sollte verblindet erfolgen (Teilnehmer/-innen und Untersucher/-innen). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Efficacy Secondary analyses will be carried out to investigate whether the combination of treatment-as-usual + CBM can achieve a greater reduction in daily cigarette consumption, a greater reduction of tobacco dependence (CO measurement, Cigarette Dependence Scale, Brief Questionnaire of Smoking Urges) at the post-assessment and a greater reduction in daily cigarette consumption and tobacco dependence (Cigarette Dependence Scale) at the 6-month follow-up compared to the control groups. Finally, it should be examined whether the interventions have an influence on the subjective impairments caused by physical and psychological symptoms (Brief Symptom Inventory). 2. Working mechanisms Additionally, possible working mechanisms will be investigated. So far, it has not been systematically examined whether effects of CBM (based on the Approach-Avoidance Task) is due to (a) the postulated reduction of implicit approach tendencies to smoke-relevant stimuli (as assessed with the Approach-Avoidance Task) or (b) the change of other processes, for example the devaluation of the stimuli (as assessed with the Implicit Association Task [valence]). Furthermore, it will be investigated whether effects of CBM generalize to another paradigm aiming to assess approach tendencies (as assessed with the Implicit Association Task [approach-avoidance]) generalize and whether reacitvity (psychophysiology EMG, acoustic startle) for smoking-related stimuli changes. Finally, it should be examined whether the automatic processes are affected by treatment-as-usual . | — |
Countries
Germany
Contacts
Public ContactCharlotte Wittekind
Ludwig-Maximilians-Universität MünchenLehrstuhl für Klinische Psychologie und Psychotherapie
Outcome results
None listed